United States· US:68083-527_daec1549-17b5-483b-8efe-55b936be5174

Dexmedetomidine

A dexmedetomidine product containing dexmedetomidine hydrochloride, registered in United States by Gland Pharma Limited. The same ATC class is registered in 17 of our 19 countries.

ATC N05CM18US label

Checked against FDA National Drug Code directory (United States) on September 27, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about dexmedetomidine hydrochlorideAnswers with sources · free account Check interactionsSeverity free · mechanism on Growth

Where it is registered

Dexmedetomidine is registered in 17 of 19 countries.

Countries holding a registration under ATC N05CM18 (dexmedetomidine), each read from that country’s own register.

This record: United States, from FDA National Drug Code directory (United States)
9 of them publish a price we can compare per daily dose

Search dexmedetomidine products by name

Dexmedetomidine · ATC N05CM18

17 / 19 countries

Belgiumprice
Canada
Czechiaprice
Denmark
Finlandprice
Franceprice
Germany
Icelandprice
Ireland
Japan
Netherlands
Norwayprice
Polandprice
Sweden
Switzerlandprice
United Kingdom
United Statesprice

Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)

Active substance: DEXMEDETOMIDINE HYDROCHLORIDE
Manufacturer: Gland Pharma Limited
Country: United States (US)
ATC code: N05CM18
ATC class: Dexmedetomidine
Defined daily dose: 1 mg, P
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: September 27, 2026

Packs & prices · 2

ndc11
68083-527-25
ndc11
6808352725
25 VIAL in 1 CARTON (68083-527-25) / 2 mL in 1 VIAL

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

79 interactions on record for dexmedetomidine.

Graded by severity as the source publishes them — 60 moderate. Severity grades are free for everyone; mechanism and management come with Growth.

Severity for every pair — free, no plan needed
The source, licence and sync date on every record
Mechanism and what to do for each pair — Growth plan

Check dexmedetomidine against other medicines How interaction checks work

Dexmedetomidine · interactions on record

79 records

60 moderate
19 info

Most severe, free to view

PapaverineA03AD01moderate
DiphenhydraminA04AB05moderate
DronabinolA04AD10moderate
NabiloneA04AD11moderate

Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.

Mechanism and what to do, in the interaction check

Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Dexmedetomidine in 15 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All dexmedetomidine products

Authorised across Europe · EMA

The same active substance is authorised in 31 EEA countries. Names it is sold under:

Austria · Dexmedetomidin Altan, Dexmedetomidin Altan Pharmaceuticals, S.A.
Belgium · Dexmedetomidine A.Forall, Dexmedetomidine Baxter
Bulgaria · Dexmedetomidine Ever Valinject, Dexmedetomidine Kalceks
Cyprus · Dexmedetomidine Baxter, Dexmedetomidine Ever Valinject
Czechia · Dexmedetomidine B. Braun, Dexmedetomidine Ever Pharma
Germany · Dexmedetomidin B. Braun, Dexmedetomidin Baxter
Denmark · Dexmedetomidin Kalceks, Dexmedetomidin Viatris
Estonia · Dexmedetomidine Auxilia, Dexmedetomidine Kabi
Spain · Dexmedetomidina Altan, Dexmedetomidina B. Braun
Finland · Dexmedetomidine B. Braun, Dexmedetomidine Baxter
France · Dexmedetomidine Altan, Dexmedetomidine Ever Pharma
United Kingdom (Northern Ireland) · Dexmedetomidine 100 Micrograms/Ml Concentrate For Solution For Infusion, Dexmedetomidine Altan Pharma
Greece · Dexmedetomidine /Kabi, Dexmedetomidine Ariti
Croatia · Deksmedetomidin Kabi, Deksmedetomidin Kalceks
Hungary · Dexmedetomidin Ever Pharma, Dexmedetomidine Kabi
Ireland · Dexmedetomidine As Kalceks, Dexmedetomidine B. Braun
Iceland · Dexdor, Dexmedetomidine Rph Pharma
Italy · Dexmedetomidina Galenica Senese, Dexmedetomidina Hikma
Liechtenstein · Dexdor
Lithuania · Dexmedetomidine Kabi, Dexmedetomidine Kalceks
Luxembourg · Dexmedetomidine Baxter, Dexmedetomidine Kabi
Latvia · Dexmedetomidine Kalceks, Dexmedetomidine Pharmidea
Malta · Dexmedetomidine Ever Valinject
Netherlands · Dexmedetomidine Altan Pharmaceuticals, S.A., Dexmedetomidine B. Braun
Norway · Dexdor, Dexmedetomidine B. Braun
Poland · Dexmedetomidine Ever Pharma, Dexmedetomidine Farmak
Portugal · Dexmedetomidina A.Forall, Dexmedetomidina Acure
Romania · Dexmedetomidină Kabi, Dexmedetomidină Kalceks
Sweden · Dexmedetomidine B. Braun, Dexmedetomidine Baxter
Slovenia · Deksmedetomidin Kalceks, Deksmedetomidin Viatris
Slovakia · Dexmedetomidine B. Braun, Dexmedetomidine Ever Pharma

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload

GET /v1/drugs/7a8c889e-c9e1-4ad2-b45e-cd0b5c0cc011
GET /v1/drugs/7a8c889e-c9e1-4ad2-b45e-cd0b5c0cc011?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "INTRAVENOUS",
  "source": "ndc",
  "strength": "100",
  "substance": "DEXMEDETOMIDINE HYDROCHLORIDE",
  "productndc": "68083-527",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "strength_unit": "ug/mL",
  "application_number": "ANDA202126",
  "marketing_category": "ANDA"
}

API reference MCP server Plans

See everything about dexmedetomidine.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

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